510(k) Report

FDA applicant

Spacelabs Burdick, Inc.

South West Ranches, FL1 decision2001–20010 recalls

FDA records 1 decision for Spacelabs Burdick, Inc. (South West Ranches, FL) in 2001: 1 510(k) clearance. All are in product code DSI (Detector And Alarm, Arrhythmia). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Spacelabs Burdick, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spacelabs Burdick, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Spacelabs Burdick, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DSIDetector And Alarm, Arrhythmia1decision

Who builds on its devices?

Later devices cite its devices 2 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011339Quest Exercise Stress System, Model Configuration 14Spacelabs Burdick, Inc. · 20012cite it

What has FDA decided for it lately?

  • K011339Quest Exercise Stress System, Model Configuration 14Spacelabs Burdick, Inc. · 2001

The one decision as Spacelabs Burdick, Inc. →

Other applicant names beginning “Spacelabs”

FDA records each applicant name separately; these may or may not be the same firm.

Spacelabs, Inc. 46Spacelabs Medical, Inc. 35Spacelabs Healthcare 20Spacelabs Healthcare Medical Equipment (Suzhou) CO 1